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Clinical efficacy and safety of Wenyang Jiedu Granules (WYJDG) in the treatment of severe community-acquired pneumonia (SCAP) : a protocol of randomized controlled clinical trial

Clinical efficacy and safety of Wenyang Jiedu Granules (WYJDG) in the treatment of severe community-acquired pneumonia (SCAP) : a protocol of randomized controlled clinical trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000877
Enrollment
Unknown
Registered
2025-04-28
Start date
2025-05-01
Completion date
Unknown
Last updated
2025-05-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Severe community-acquired pneumonia

Interventions

Control group:Conventional Western medicine treatment including drug therapy (antibiotics corticosteroids etc.) if necessary mechanical ventilation support. On this basis, Wenyang Jiedu granule placeb
Treatment group:Conventional Western medicine treatment, including drug therapy (antibiotics, corticosteroids, etc.), if necessary, mechanical ventilation support. On this basis, Wenyang Jiedu granule

Sponsors

Guangdong Provincial Hospital of Chinese Medicine Dade Road General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) The diagnosis criteria of severe community-acquired pneumonia were met (2) Meet the diagnostic criteria of TCM diseases (3) Clear diagnosis of severe community-acquired pneumonia within 48 hours (4) Patients aged 18-80 years (5) Sign or authorize the signing of informed consent.

Exclusion criteria

Exclusion criteria: (1) APACHE II score >30 or SOFA score >12 (2) Septic shock occurs or the mean arterial pressure (MAP) remains 20mg prednisone daily or equivalent dose of glucocorticoids for 1 month or more before screening or cumulative >600mg prednisone equivalent dose of glucocorticoids for 1 month before screening) those undergoing transplantation and those infected with HIV (5) People who are allergic to multiple drugs and have a history of allergy to investigational drugs and their ingredients (6) Pregnant or lactating patients (7) Those who are participating in other drug clinical trials or have participated in other clinical trials within 1 month (8) Patients with enteral nutrition disorders or patients with clinical requirements for fasting

Design outcomes

Primary

MeasureTime frame
Clinical status improvement rate within 28 days;

Secondary

MeasureTime frame
ICU stay;Score on a 6-point scale;28-day case fatality rate;Inflammatory factor;Inflammatory blood count;PSI score;SOFA scoring;Day 28 Non-mechanical ventilation days;Length of stay;Inflammatory index;Evaluation of curative effect of traditional Chinese medicine;

Countries

China

Contacts

Public ContactXi Xiaotu

Guangdong Provincial Hospital of Chinese Medicine Dade Road General Hospital

xixiaotu@163.com+86 139 2955 6092

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026